Today, the US FDA announced the approval of SIGA Technologies’ new drug TPOXX (tecovirimat) for the treatment of smallpox. It is worth mentioning that this is the 21st new drug approved by the US FDA this year and the first new drug approved for the treatment of smallpox.
The name of the smallpox, the readers of the biomedical industry will not be unfamiliar. The smallpox vaccine is the first vaccine successfully developed by humans, and we have the weapon to prevent this deadly disease. Since the vaccination of smallpox vaccines, humans have won a victory in the war against viruses. In 1980, the World Health Organization announced that we have eliminated the threat of smallpox. This kind of infectious disease, which has been widely affected and has been talked about, has gradually faded out of people’s horizons.
But with the complexity of the international situation in these decades, people began to worry that the smallpox virus may be made into biological weapons, threatening the lives of ordinary people. Therefore, people also decided to develop a drug that can treat smallpox in case of emergency. TPOXX came into being. As an antiviral drug, it can effectively target the spread of variola virus in the body. Based on its potential, this new drug has been granted fast track qualifications, priority review qualifications, and orphan drug qualifications.
The efficacy and safety of this new drug have been tested in animal and human trials, respectively. In animal experiments, animals infected with TPOXX lived longer than those treated with placebo after infection with variola virus. In human trials, the researchers recruited 359 healthy volunteers (without smallpox infection) and asked them to use TPOXX. Studies have shown that the most common side effects are headache, nausea, and abdominal pain without serious side effects. Based on the efficacy demonstrated in animal experiments and the safety demonstrated by human trials, the FDA approved the launch of the new drug.
“In response to the danger of bioterrorism, Congress has taken steps to ensure that pathogens are used as weapons, and we have developed and approved counter-measures. Today’s approval represents a major milestone in these efforts!” FDA Director Scott Gottlieb The doctor said: “This is the first new drug to be awarded the ‘Material Threat Medical Countermeasure’ priority review. Today’s approval also demonstrates the FDA’s commitment to ensuring that we are ready for a public health crisis and provide timely security. Effective new drug products.”
Although this new drug is expected to treat smallpox, we still expect that the smallpox will not make a comeback, and we look forward to the day when humans will never use this new drug.
Post time: Jul-17-2018